BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 23600454 · Received November 19, 2025

    Report

    Report Number
    1213809-2025-00729
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 29, 2025
    Report Date
    February 19, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE CLAIM IS CLASSIFIED AS UNCONFIRMED, AS THERE ARE NO PHYSICAL SAMPLES OR PHOTOGRAPHIC EVIDENCE AVAILABLE TO VERIFY THE CONDITION OF THE SYRINGE. IT IS IMPORTANT TO MENTION THAT NO QUALITY EVENTS RELATED TO THE REPORTED DEFECT WERE FOUND IN THE BATCH RECORD DURING PRODUCT MANUFACTURING.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL 200 S/C HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: LEAKING 3 CC SYRINGES - "WE DRAW UP BLOOD OR LIQUID (COULD BE MEDICATION) INTO THE SYRINGE, IT SEEMS TO BE DRIPPING OUT". ADDITIONAL INFORMATION PROVIDED: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ADVERSE EVENTS OR INJURIES REPORTED. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? 5162816. PLEASE CLEARLY SPECIFY THE LOCATION OF THE PRODUCT LEAK. THE LEAK IS COMING OUT OF THE TIP OF THE SYRINGE WHERE THE LIQUID WOULD TYPICALLY COME FROM IF THE SYRINGE LEVER WAS PRESSED. WHERE WAS THE PRODUCT PLACED IN THE BODY? NOT PLACED IN/ON BODY. USED TO DRAW BLOOD OFF OF AN IV LINE WHEN THE BLOOD INSIDE OF THE SYRINGE WAS FOUND TO BE LEAKING OUT. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? BLOOD. TOTAL NUMBER OF OCCURRENCES? THREE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28636 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5162816 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown